Document Type

Department

Obstetrics and Gynaecology

Abstract

Objective: To determine the reasons underlying the refusals to participate and drop outs from a follow up study involving primigravidae.

Design: A descriptive study.

Methods: Aga Khan University and Aga Khan Hospital for Women, Karachi, jointly initiated a nested case-control study on primigravidae for determining the predictability of preeclampsia using various biochemical markers in blood. The protocol-eligible study subjects were counseled along with their accompanying family members to participate in the study. All women recruited in this study were followed up throughout their pregnancy till delivery.

Results: One thousand six hundred and sixty-five primigravidae were identified as the potential study subjects. Out of which, 1,307 (78.5%) consented and 358 (21.5%) refused to participate in the study. The most common reason underlying the refusal was inability to get permission from the family members (n = 84; 34.4%) followed by fear of prick (n = 51; 20.9%). For 114 refusals, either the reason was not mentioned by the counseled women (n = 60) or the data was missing (n = 54). Out of 1,307 women recruited in the research, only 611 (46.7%) women completed the study according to the prescribed protocol. Among the rest, 102 (7.8%) subsequently withdrew from the research, 503 (38.5%) were dropped out, and 91 (7.0%) were lost to follow up.

Conclusions: Refusal to participate and drop out from the research program are two significant factors hindering the smooth flow of a study. In Pakistan, the major reason for the refusal by the protocol-eligible pregnant women for participating in a research program is the unwillingness of the family members.